The United States government has been taking a firmer stance regarding cannabis. In his proposed budget for the 2021 fiscal year, President Trump planned on ending an existing policy that protects state medical marijuana programs from Justice Department interference. In simpler terms, the policy, which has been renewed every year since 2014, does not allow the Justice Department to use its funds to prevent states or territories from setting their own medical marijuana laws. This is only one part of a federal effort to increase regulations in the interest of safety. The reason for this is because “There is a significant gap in our understanding of their impact on health,” according to Nora Volkow, Director of NIDA. Recent outbreaks of e-cigarette and vaping associated lung injury (EVALI) from informally sourced THC vape products underscore the need for researchers to have access to different product sources.
Additionally, the budget proposal prevents Washington, D.C. from using local tax dollars to legalize marijuana sales. Separate from this, funds will be set aside to help the Food and Drug Administration (FDA) in regulating cannabis. The agency acknowledges the opportunities and potential of cannabis and cannabis-derived compounds while realizing that growing markets are quickly outpacing increases to agency resources.
In the spring of 2019, the FDA teamed up with the Federal Trade Commission and issued warning letters to three CBD product sellers for their health claims without FDA approval. Later in the year, this resulted in two class-action lawsuits that claimed the sellers mislabeled their products under federal regulations. Because of the concern on how cannabidiol products currently affect the body, it is illegal to market these products as dietary supplements or food additives.
In spite of the increased measures surrounding cannabis regulation, MMJ International Holdings, the premier medical cannabis research company remains steadfast in its efforts to follow the necessary federal protocol in its drug development process. In aligning with the president’s mandate, the company has filed its Investigational New Drug (IND) applications with the FDA for its proprietary formulation of THC and CBD. Soon, MMJ International Holdings will be initiating clinical trials in Multiple Sclerosis and Huntington’s Disease.
MMJ’s recent major milestones include approval from the DEA for its THC and CBD international shipment to the United States for further development of its plant-derived cannabinoid drug as well as Orphan Drug Designation for its Huntington’s drug formulation.